Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 11:53 PM
Ignite Modification Date: 2025-12-25 @ 9:48 PM
NCT ID: NCT01889251
Description: An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Ocular adverse events are presented for both study eye and non-study eye.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected for the duration of the study (1 year, 2 months). This analysis group includes all subjects who received study medication, as treated. Note: One subject randomized to Ocriplasmin was inadvertently treated with Sham.
Study: NCT01889251
Study Brief: A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sham Injection Single sham injection to the study eye at baseline None None 4 58 19 58 View
Ocriplasmin Single intravitreal injection to the study eye at baseline None None 23 114 63 114 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Macular hole None Eye disorders MedDRA/J (16.0) View
Cervix carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J (16.0) View
Vitreous adhesions None Eye disorders MedDRA/J (16.0) View
Pneumonia None Infections and infestations MedDRA/J (16.0) View
Retinal detachment None Eye disorders MedDRA/J (16.0) View
Spinal compression fracture None Injury, poisoning and procedural complications MedDRA/J (16.0) View
Asthma None Respiratory, thoracic and mediastinal disorders MedDRA/J (16.0) View
Ocular hypertension None Eye disorders MedDRA/J (16.0) View
Angle closure glaucoma None Eye disorders MedDRA/J (16.0) View
Intraocular pressure increased None Investigations MedDRA/J (16.0) View
Malignant melanoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA/J (16.0) View
Macular pseudohole None Eye disorders MedDRA/J (16.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vitreous floaters None Eye disorders MedDRA/J (16.0) View
Anterior chamber cell None Eye disorders MedDRA/J (16.0) View
Eye pain None Eye disorders MedDRA/J (16.0) View
Back pain None Musculoskeletal and connective tissue disorders MedDRA/J (16.0) View
Conjunctival hyperaemia None Eye disorders MedDRA/J (16.0) View
Visual impairment None Eye disorders MedDRA/J (16.0) View
Corneal disorder None Eye disorders MedDRA/J (16.0) View
Punctate keratitis None Eye disorders MedDRA/J (16.0) View
Retinal detachment None Eye disorders MedDRA/J (16.0) View
Intraocular pressure increased None Investigations MedDRA/J (16.0) View
Constipation None Gastrointestinal disorders MedDRA/J (16.0) View
Conjunctival haemorrhage None Eye disorders MedDRA/J (16.0) View